FDA.reportPublic FDA data

Red Cell Storage Solution

Primary DI
00858400005114
Brand
Red Cell Storage Solution
Company
American National Red Cross
Model
510265
Device description
Red Cell Storage Solution is intended for use in the dilution and/or preservation of human red blood cells (RBCs) for the purposes of in vitro immunohematology testing.
Published
2020-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GIFDiluent, Blood Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIFDiluent, Blood CellHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858400005114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858400005114008584000051148584000051140858400005114

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell preservation/storage/dilution solution IVDA solution intended to be used for the preservation, storage, dilution and/or resuspension of blood cells (e.g., red blood cells, white blood cells) in a whole blood specimen or a cell isolate following separation from whole blood, to maintain cell stability and/or facilitate further in vitro diagnostic testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
003255213
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858400005138Anti-C (Human/Murine Monoclonal)5101462026-03-06
00858400005145Anti-c (Human/Murine Monoclonal)5101472026-03-06
00858400005152Anti-S (Human/Murine Monoclonal)5101532026-03-06
00858400005169Anti-s (Human/Murine Monoclonal)5101542026-03-06
00858400005176Anti-k (Human/Murine Monoclonal)(IgG)5101492026-03-06
00858400005183Anti-E (Human/Murine Monoclonal)5101482026-03-06
00858400005190Anti-Jka (Human/Murine Monoclonal)5101512026-03-06
00858400005206Anti-Jkb (Human/Murine Monoclonal)5101522026-03-06
00858400005091Control Cells510400/5104022016-07-21
00858400005107PEG5101792018-09-17
00858400005121LISS5101772018-09-17
00858400005008Anti-K5102002014-09-12
00858400005015Anti-k5102022014-11-04
00858400005022Anti-Kpa5102042014-09-12
00858400005039Anti-Kpb5102052014-09-12
00858400005046Anti-M5102062014-09-12
00858400005053Anti-S5102222014-09-12
00858400005060Anti-s5102242014-09-12
00858400005077Anti-Fya5102152014-09-12
00858400005084DailyChek QC Kit5103952016-07-21

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Primary DI, Brand, Company table
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